This article was originally published in The Gray Sheet
Executive SummaryThe Association for the Advancement of Medical Instrumentation publishes revision of the American National Standard Safe Current Limits for Electomedical Apparatus. The standard is intended to be "substantially harmonized" with the International Electrotechnical Commission's 601-1 standard. AAMI also issues a standard on pacemaker emergency intervention systems, a revised set of recommended practices on human factors engineering in the design of medical devices, and six standards on biological evaluation of medical devices
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